Senior Process Engineer

Synectics Inc.; Indianapolis (IN); On-site; USD 88,000; Full time

Job summary

An established industry player is seeking a Senior Process Engineer to lead engineering activities in a dynamic environment. This role involves executing design, maintenance, and optimization projects while ensuring compliance with GMP standards. The ideal candidate will have a strong background in the pharmaceutical industry and a knack for troubleshooting complex systems. You will be at the forefront of driving continuous improvement initiatives, enhancing equipment reliability, and ensuring project timelines are met. Join a team that values innovation and quality, where your expertise will have a significant impact on operational excellence.

Benefits

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Technical Certification Bonus

Qualifications

• 5+ years of experience in a GMP environment.
• Experience in the pharmaceutical industry is required.

Responsibilities

• Execute engineering activities and ensure project objectives.
• Lead root cause investigations and manage deviations.
• Support audits and provide customer satisfaction.

Skills

GMP Experience

Project Management

Root Cause Analysis

Technical Troubleshooting

Automation Knowledge

Education

Bachelor's Degree in Engineering

Tools

CMMS System

Scada

PLC

Job description

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• The Process Engineer will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives.
• Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level.
• Execute for design, execution and hand-over projects within cost, time schedule, quality and functionality within technical area of responsibility.
• Flexible to support second shift when needed to ensure the project's critical timeline is maintained.
• Guide and supervise onsite installation and commissioning activities of equipment/system
• Install subsystems in production line
• Implement equipment optimizations and modifications
• Participate on the assessment or implementation of special projects or initiatives with cross-functional teams.
• Lead complex root cause investigations
• Performs change assessments
• Preparing, scheduling, coordinating, and monitoring of assigned engineering projects.
• Reviews equipment and engineering systems to support root cause analysis investigations and trend investigations.
• Second line escalation in case of equipment failures
• Driving continuous improvement from an asset perspective
• Reducing safety risks through simplification and error proofing machines
• Improving equipment reliability through equipment design modifications
• Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
• Set-up maintenance for new equipment (incl. spare part needs).
• Assist with preparation of plans for maintenance / calibration / qualifications.
• Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
• Assist with preparation of estimates for bids and proposals.
• Act as SME to review/approve DQ, IQ, OQ and PQ protocols and reports.
• Independently manage and resolve deviations on equipment and systems.
• Support internal and external audits.
• Provide technical trouble shooting during Startup, PQ and validation activities
• Develop periodic requalification plan
• Execute periodic requalification plan
• Utilize automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities
• Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.
• Write/revise accurate engineering documents for various production system.
• Supply information and technical data for securing spare parts.
• Provide responsive customer support with emphasis on customer satisfaction.
• Perform startup and commissioning activities as required.
• Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs
• Complete and provide accurate documentation, as required in cGMP operations.
• Use of CMMS system for documentation of relevant work.
  
  

Description

• The Process Engineer will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives.
• Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level.
• Execute for design, execution and hand-over projects within cost, time schedule, quality and functionality within technical area of responsibility.
• Flexible to support second shift when needed to ensure the project's critical timeline is maintained.
• Guide and supervise onsite installation and commissioning activities of equipment/system
• Install subsystems in production line
• Implement equipment optimizations and modifications
• Participate on the assessment or implementation of special projects or initiatives with cross-functional teams.
• Lead complex root cause investigations
• Performs change assessments
• Preparing, scheduling, coordinating, and monitoring of assigned engineering projects.
• Reviews equipment and engineering systems to support root cause analysis investigations and trend investigations.
• Second line escalation in case of equipment failures
• Driving continuous improvement from an asset perspective
• Reducing safety risks through simplification and error proofing machines
• Improving equipment reliability through equipment design modifications
• Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
• Set-up maintenance for new equipment (incl. spare part needs).
• Assist with preparation of plans for maintenance / calibration / qualifications.
• Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
• Assist with preparation of estimates for bids and proposals.
• Act as SME to review/approve DQ, IQ, OQ and PQ protocols and reports.
• Perform GMP risk assessments (incl. Sensors SRA).
• Independently manage and resolve deviations on equipment and systems.
• Support internal and external audits.
• Provide technical trouble shooting during Startup, PQ and validation activities
• Develop periodic requalification plan
• Execute periodic requalification plan
• Utilize automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities
• Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.
• Write/revise accurate engineering documents for various production system.
• Supply information and technical data for securing spare parts.
• Provide responsive customer support with emphasis on customer satisfaction.
• Perform startup and commissioning activities as required.
• Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs
• Complete and provide accurate documentation, as required in cGMP operations.
• Use of CMMS system for documentation of relevant work.
  
  

Requirements

• Bachelor's Degree in Engineering or related field is required
• 5+ years of relevant experience in a GMP environment is required
• Previous experience in the pharmaceutical industry is required.
• Pharmaceutical aseptic filling experience is preferred
• Vendor management experience is a plus
• Knowledge/experience in automation or computer system validation (CSV) is a plus
• Experience managing projects is preferred
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Staffing and Recruiting

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